Infuset-4000
by EMED Technologies Corporation
Infuset-4000 (FP-0010028) is a Class II device made by EMED Technologies Corporation, cleared under FDA 510(k) K140133 on 15 May 2014 and listed in FDA GUDID since 25 Apr 2017 (UDI-DI 00817708021929), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817708021929 | Date25 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140133 | Date15 May 2014 | StatusActive |
Official records
- AccessGUDID record 00817708021929
- FDA 510(k) database K140133
Across registries
- FDA 510(k) K140133 decided 15 May 2014 Active
- FDA GUDID UDI-DI 00817708021929 listed 25 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K140133
- Listed FDA GUDID 00817708021929
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Infuset
- Generic name
- Mechanical infusion pump administration set
- Model / Ref / Catalog
- Infuset-4000, FP-0010028
- Primary DI / UDI-DI
- 00817708021929
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Mechanical infusion pump administration set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 7.03 CentimeterTotal Volume — 0.06 Milliliter
Similar devices in this category
Other devices filed under Mechanical infusion pump administration set.